K992777

Unknown

CONSTELLATION CATHETERS, MODEL 8039

Applicant
Boston Scientific Corp
Product code
MTD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Unknown
Clearance type
Special
Location
San Jose, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MTD

product code MTD
Death
22
Injury
376
Malfunction
986
Total
1,384

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.